Many quality standards, such as ISO 13485:2016, outline specific requirements for quality management systems of medical devices which must be demonstrated to show that the device meets all applicable regulatory requirements.
A QMS certified to ISO 13485 is required for medical devices in Canada, and will also help in meeting the compliance requirements in the European Union. However, in the United States, your medical device must comply with FDA Quality System Regulations (QSR) and FDA 21 CFR Part 820.
dicentra can help provide the following services to help you meet the QMS requirements for your medical device:
- Strategy and risk analysis
- QMS design and development
- QMS audit and assessment against ISO 13485 standards
- QMS audit and assessment against FDA QSR
- QMS audit and assessment against FDA 21 CFR Part 820
- QMS verification and improvement
- SOP & PnP preparation and review
- Third-party Medical Device Single Audit (MDSAP)
Contact our medical device specialists using the form below to help you meet the QMS requirements for your medical device.